GPED for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma

Beijing Tongren Hospital (Other)
Overall Status
Recruiting ID

Study Details

Study Description

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of GPED (gemcitabine, pegaspargase, etoposide, and dexamethasone) regimen in the treatment of Relapsed/Refractory or advanced NK/T-cell lymphoma patients

Study Design

Study Type:
Anticipated Enrollment :
15 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Official Title:
Gemcitabine, Pegaspargase, Etoposide, and Dexamethasone (GPED) for Patients With Relapsed/Refractory or Advanced NK/T-cell Lymphoma : a Single Arm,Open-lable,Phase II Study
Actual Study Start Date :
Mar 20, 2020
Anticipated Primary Completion Date :
Jun 30, 2021
Anticipated Study Completion Date :
Aug 31, 2021

Arms and Interventions

Arm Intervention/Treatment
Experimental: treatment arm

Treated with gemcitabine, pegaspargase, etoposide and dexamethasone

Drug: Gemcitabine
1000mg/㎡,d1,4 ivdrip

Drug: Pegaspargase
2500IU/㎡, maximum dose less than 3750IU

Drug: Etoposide
100mg/㎡,d1-3 ivdrip

Drug: Dexamethasone
20mg/d d1-4 ivdrip

Outcome Measures

Primary Outcome Measures

  1. overall response rate [24 weeks ±7 days]

    evaluated by PET-CT and MRI, according to Lugano 2014 criteria

Secondary Outcome Measures

  1. complete response rate [24 weeks ±7 days]

    evaluated by PET-CT and MRI, according to Lugano 2014 criteria

  2. 1-year progression free survival rate [up to 1year after enrollment]

    time from date of enrollment to date of disease progression, death of any reason, whichever comes first

  3. 1-year overall survival rate [up to 1year after enrollment]

    time from date of enrollment to date death of any reason

Eligibility Criteria


Ages Eligible for Study:
16 Years to 75 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:

Histopathology and immunohistochemistry confirmed diagnosis of NK/Tcell lymphoma according to WHO 2016 criteria.

  • refractory or relapsed after initial remission, or stage III-IV de novo patients

  • PET/CT or CT/MRI with at least one objectively evaluable lesion.

  • General status ECOG score 0-3 points.

  • The laboratory test within 1 week before enrollment meets the following conditions: Blood routine: Hb>80g/L, PLT>50×10e9/L. Liver function: ALT, AST, TBIL ≤2 times the upper limit of normal. Renal function: Cr is normal. Cardiac function: LVEF≥50%, ECG does not suggest any acute myocardial infarction, arrhythmia or atrioventricular conduction above I Blocking.

  • Sign the informed consent form

Exclusion Criteria:

Active infection requires ICU treatment. Concomitant HIV infection or active infection with HBV, HCV. Patients who are infected with HBV but not active hepatitis at the same time are notexcluded.

Significant organ dysfunction Pregnant and lactating women. Had a history of autoimmune diseases, and disease was active in the last 6 months.

Those who were known to be allergic to drugs in the study regimen. Patients with other tumors who require surgery or chemotherapy within 6 months.

• Other experimental drugs are being used.

Contacts and Locations


Site City State Country Postal Code
1 Beijing Tongren Hospital Beijing China 100730

Sponsors and Collaborators

  • Beijing Tongren Hospital


  • Principal Investigator: Liang Wang, M.D., Beijing Tongren Hospital

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
LIANG WANG, Director of Dept. of Hematology, Beijing Tongren Hospital, Beijing Tongren Hospital Identifier:
Other Study ID Numbers:
  • TRhos-ENKTCL-7
First Posted:
Jun 8, 2021
Last Update Posted:
Jun 8, 2021
Last Verified:
Jun 1, 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 8, 2021